(159 days)
The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.
The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous steerable sheath with a flexible tip designed for gaining access to the vasculature including the coronary systems. It is comprised of two (2) main sections: the shaft and the handle. The Z°Flex-270 Steerable Sheath has uni-directional adjustable tip geometry with a rotating mechanism on the handle used to control sheath deflection. A dilator and guidewire are included with each kit.
The provided text describes the Z°Flex-270™ Steerable Sheath, a medical device, and its safety and substantial equivalence to a predicate device. This document is a 510(k) summary submitted to the FDA. It outlines the device's description, indications for use, and a comparison to a predicate device, focusing on technological characteristics and performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present explicit "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it states that the device "met all specifications per functional and performance requirements" without detailing those specifications.
However, based on the performance (bench) testing listed, we can infer the categories of acceptance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Visual Assessment | Met specifications |
| Dimensional Accuracy | Met specifications |
| Functional: Hemostasis valve leak testing | Met specifications |
| Functional: Deflection testing | Met specifications |
| Functional: Air aspiration and hemostasis | Met specifications |
| Functional: Fatigue testing (deflection) | Met specifications |
| Sheath tip robustness after multiple deployment/retractions | Met specifications |
| Kink resistance | Met specifications |
| Torque | Met specifications |
| Tensile testing | Met specifications |
| Dilator to sheath retention | Met specifications |
| Guidewire testing | Met specifications |
| Biocompatibility | |
| Cytotoxicity | Met specifications |
| Sensitization | Met specifications |
| Irritation/Intracutaneous Reactivity | Met specifications |
| Acute Systemic Toxicity | Met specifications |
| Materials Mediated Rabbit Pyrogen | Met specifications |
| Hemolysis | Met specifications |
| Partial Thromboplastin Time | Met specifications |
| Platelet and Leukocyte Counts | Met specifications |
| Complement Activation | Met specifications |
| Thrombosis (In-vivo) 4 hour contact | Met specifications |
| Testing for Latex, DEHP, and Bisphenol A | Met specifications |
| Sterilization | Met specifications |
| Shelf Life | Met specifications |
| Packaging | Met specifications |
2. Sample size used for the test set and the data provenance:
- Sample size: The document states that "representative finished, sterilized samples of the subject device underwent the following testing" but does not specify the exact number of samples used for any of the individual tests. This information is typically detailed in the full test reports, not usually in a 510(k) summary.
- Data provenance: The testing performed is described as "Performance (bench) testing" and "biocompatibility testing." This indicates the data provenance is from laboratory bench testing and in-vitro/in-vivo animal studies (for biocompatibility), not human clinical trials. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are usually applicable to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the described study. The study involves bench and biocompatibility testing of a medical device, not a diagnostic or AI device that requires expert interpretation to establish "ground truth." The "ground truth" for these tests would be the established scientific and engineering standards and methods against which the device's physical and biological properties are measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable to the described study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where multiple human readers or experts provide independent assessments, and a method is needed to resolve discrepancies. The provided document describes laboratory testing where results are typically objectively measured and compared against predefined specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable to the described study. An MRMC study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance. The Z°Flex-270™ Steerable Sheath is an interventional medical device, not a diagnostic AI system. The study described focuses on the device's physical and biological performance characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable to the described study for the same reasons as above. This refers to the standalone performance of an AI algorithm, which is not what is being evaluated here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical performance tests, the "ground truth" (or reference) would be engineering specifications, industry standards (e.g., ISO 11070), and functional requirements defined by the manufacturer. These are objective, measurable criteria.
- For the biocompatibility tests, the "ground truth" refers to established biological safety criteria and test methodologies (e.g., ISO 10993 series, though not explicitly cited beyond specific biological tests). The results are compared against acceptable levels of biological response.
8. The sample size for the training set:
- This question is not applicable. The device is an interventional medical catheter, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing process would involve internal testing and validation, but not in the sense of a machine learning training set.
9. How the ground truth for the training set was established:
- This question is not applicable, as there is no training set for this type of medical device.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).